FDA 510(k)

MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL

K-Number: K003144 · 2000-12-13

Decision Date2000-12-13

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Advances, Inc.. It received FDA 510(k) clearance on 2000-12-13 under 510(k) number K003144. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL?

MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Medical Advances, Inc.. The 510(k) number is K003144.

When did MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL receive FDA 510(k) clearance?

MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL received FDA 510(k) clearance on 2000-12-13, under 510(k) number K003144.

Who is the listed applicant for MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL?

The FDA 510(k) record lists Medical Advances, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL?

The FDA product code for MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL is MOS.

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Other records listing Medical Advances, Inc. as applicant

K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL K021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL K011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL K010074MODEL 455GE PHASED ARRAY WRIST COIL K003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL K000345MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.